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CompletedNCT02170077Updated Aug 18, 2017Results posted

A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093

A Phase 2 interventional study of BIA 2-093 and Placebo in Epilepsy, sponsored by Bial - Portela C S.A.. Completed at 1 site in Portugal. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-18.

Sponsored by Bial - Portela C S.A. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

Read the detailed description

This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

02

Conditions studied

  • Epilepsy

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Keywords

  • Epilepsy
  • BIA 2-093
03

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's enrollment of 144 is above the median of 50 across 1,228 interventional studies indexed under Epilepsy.

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Lead sponsor

Bial - Portela C S.A. is the lead sponsor of 136 studies on the registry; 1 is open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female patients aged 18-65 years
  • Patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit
  • At least 4 seizures per month within the last 2 months prior to randomisation
  • Stable dose regimen of a maximum of two of the following AEDs: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation
  • Electroencephalogram (EEG) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy)
  • Written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patient with nervus vagus stimulation
  • Patient with primarily generalized seizures
  • Known progressive neurological disturbance
  • A history of status epilepticus within the past 3 months
  • Seizure of non-epileptic origin
  • Restricted legal competence and incapability to follow trial instructions
  • Major psychiatric disorders
  • Concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers
  • Need of excluded concomitant medication (see section 9.4.6.2)
  • Use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit
  • Known hypersensitivity to oxcarbazepine or carbamazepine, or its metabolites
  • Abuse of alcohol, drugs or medications
  • History of relevant cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, hematologic or oncology disorders
  • Second- or third-degree atrioventricular block not corrected with a pacemaker
  • Relevant laboratory abnormalities (e.g., Na+\< 130 mmol/L, alanine (ALT) or aspartate (AST) transaminase >2.0 times the upper limit of normal, white blood cell (WBC) count \<3000 cells/mm3)
  • Pregnancy, nursing or inadequate contraception in women of childbearing age (oral contraception should be combined with a barrier method)
  • Participation in other clinical trials within the last 2 months
  • History of non-compliance.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    ODG - once-daily group

    BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

    Drug: BIA 2-093

  • Experimental
    TDG - twice-daily group

    BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

    Drug: BIA 2-093

  • Placebo comparator
    PLG - placebo group

    placebo

    Drug: Placebo

Interventions

  • DrugBIA 2-093

    BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route

  • DrugPlacebo

    Placebo tablets administered orally

06

What researchers measure

Primary outcomes

  1. The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period

    Time frame: baseline, week 12

07

Results

Posted Aug 12, 2014

Participant flow

Participant flow — Overall Study
MilestoneODG - Once-daily GroupTDG - Twice-daily GroupPLG - Placebo Group
Started504747
Intent to treat (itt) population504647
Completed413435
Not completed91312
Withdrew: Withdrawal by subject342
Withdrew: Adverse event444
Withdrew: Lost to follow-up010
Withdrew: Exclusion criteria225
Withdrew: Exacerbation of seizures021

Outcome measures

PrimaryThe Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period
Time frame:
baseline, week 12
Reported as:
Number · percentage of responders
The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period
percentage of respondersODG - Once Daily GroupTDG - Twice Daily GroupPLG - Placebo Group
The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period544128

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ODG - Once Daily Group—2/50 (4%)18/50 (36%)
TDG - Twice Daily Group—0/46 (0%)19/46 (41.3%)
PLG - Placebo Group—1/47 (2.1%)21/47 (44.7%)
Most frequent serious events
Most frequent serious events
EventODG - Once Daily GroupTDG - Twice Daily GroupPLG - Placebo Group
VIRAL GASTROENTERITISInfections and infestations0/500/461/47
BACTERIAL INFECTION OF INTESTINESInfections and infestations1/500/460/47
ISCHAEMIC STROKENervous system disorders1/500/460/47
Most frequent other events
Showing 10 of 20
Most frequent other events
EventODG - Once Daily GroupTDG - Twice Daily GroupPLG - Placebo Group
HeadacheNervous system disorders2/508/463/47
VomitingGastrointestinal disorders0/505/461/47
DizzinessNervous system disorders1/505/461/47
NauseaGastrointestinal disorders2/503/462/47
Creatine kinase increasedInvestigations0/500/463/47
SomnolenceNervous system disorders3/501/460/47
Ear buzzingEar and labyrinth disorders0/502/460/47
Dry mouthGastrointestinal disorders0/502/460/47
Concentration impairedNervous system disorders1/502/461/47
Hair lossSkin and subcutaneous tissue disorders2/502/461/47

Baseline characteristics

Age, Continuous
Age, Continuous(years)ODG - Once-daily GroupTDG - Twice-daily GroupPLG - Placebo GroupTotal
Mean39.3 ± 11.439.8 ± 11.940.4 ± 10.839.8 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)ODG - Once-daily GroupTDG - Twice-daily GroupPLG - Placebo GroupTotal
Female29312787
Male21162057
08

Study locations

1 site
  • BIAL - Portela & Cª, S.A.
    S. Mamede Do Coronado, S. Mamede Do Coronado 4045-457, Portugal
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2002, a primary completion of Nov 2002 and a completion of Nov 2002. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2014, 11 years 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2014
First posted
Jun 23, 2014
Start
Apr 2002
Primary completionActual
Nov 2002
CompletionActual
Nov 2002
Results first posted
Aug 12, 2014
Last update
Aug 18, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02170077
Lead sponsor
Bial - Portela C S.A.
Responsible party
Sponsor
First posted
Jun 23, 2014
Start date
Apr 2002
Primary completion
Nov 2002
Completion
Nov 2002
Results posted
Aug 12, 2014
Last update
Aug 18, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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